(Reuters) – The U.S. Food and Drug Administration has declined to approve Sesen Bio Inc’s lead therapy candidate for a type of bladder cancer, the drug developer said on Friday.
The health regulator, in a letter to the company, said it cannot approve the marketing application for the drug, Vicineum, in its present form.
It has provided recommendations specific to additional clinical data and analyses in addition to issues pertaining to a recent pre-approval inspection and product quality, the company added.
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